Liver Cirrhosis
Conditions
Keywords
Liver transplantation, Liver cirrhosis, Branched chain amino acids, Late evening supplementation, Nutritional status
Brief summary
Assess the impact in body composition and handgrip strength of the nocturne supplementation by a month with BCAA (Enterex hepatic in patients awaiting liver transplantation)
Detailed description
Clinical trial study was make, data were obtained from people awaiting liver transplantation and with at least a criteria of protein/energy malnutrition (fase angle \< 5.4°, subjective global assessment B or C and/or handgrip strength \< 30 in men and \< 20 in women). The investigators make them body composition assessment (weight, height, body mass index \[BMI\], mean arm circumference \[MAC\], muscle arm area \[MAA\], tricipital skinfold, Dual X ray absorptiometry \[fat mass and fat free mass\]) and handgrip strength at beginning and after 30 days of nocturne supplementation with BCAA and standardized diet (35-40 Kcal, 55% carbohydrates, 25% lipids and 20% proteins).
Interventions
DIETARY_SUPPLEMENTLate evening supplementation with branched chain amino acids
The patients will drink a Enterex Hepatic bag (500 Kcal, 18.6g of proteins of which 8.63g are branched chain amino acids, 71.7g of carbohydrates and 15.4g of lipids) during late evening (after 19:00 hours) in comparison with the late evening snack group which will eat a snack based in food with the next nutrimental facts (480 Kcal, 19g of proteins based in casein and vegetables sources, 17g of lipids and 63g of carbohydrates) during the same schedule that intervention group.
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Universidad de Guanajuato
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients on waiting list for liver transplantation. * Diagnosis of undernutrition.
Exclusion criteria
* Hepatorrenal syndrome. * Hepatopulmonar syndrome * Diabetes * Overweight
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Composition | Basal and 30 and 60 days after intervention. | The body composition will be measured with air displacement pletismografy through Bodpod the results will be expressed in percentaje of fat mass and fat free mass. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mid arm muscle area | Basal and 30 and 60 days after intervention. | Estimation of muscle area of the no dominant arm using the formula \[(MAMA - (π x PT))2 / 4 π \] \- 10 in men and -6.5 in women, the result is expressed in cm2. |
| Change in Quality of life | Basal and 30 and 60 days after intervention. | It will be measured by the questionnaire SF-36 that is a generic scale providing a health profile and is applicable for both, patients and general population; the results that the 36 questions divided in 8 dimensions. The patients answers will be transformed to a numeric scale: since 0 (worst) to 100 (better) |
| Change in Fase angle. | Basal and 30 and 60 days after intervention. | vectorial sum of the resistance and reactance result in the impedance, and the angle that is formed is called the fase angle; this is obtain through a impedanciometre, the measure is expressed in grades. |
| Change in Handgrip strength. | Basal and 30 and 60 days after intervention. | Handgrip strength of the no dominant hand will be measured by a hand dynamometer in kilograms/Force |
Countries
Mexico
Contacts
Primary ContactNiko Alain Cruz Sancén
Outcome results
None listed